Suxilon 1.5g Granules for Top Dressing

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

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Download 제품 특성 요약 (SPC)
08-06-2023

유효 성분:

Suxibuzone

제공처:

Ecuphar Veterinaria S.L.U.

ATC 코드:

QM01AA90

INN (국제 이름):

Suxibuzone

약제 형태:

Oral powder

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Horses

치료 영역:

Anti Inflammatory NSAID

승인 상태:

Authorized

승인 날짜:

2011-06-14

제품 특성 요약

                                Revised: April 2022
AN: 02931/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suxilon 1.5g Granules for top dressing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 g sachet contains
ACTIVE SUBSTANCE:
Suxibuzone (microencapsulated) 1.5 g
EXCIPIENT(S):
Quinoline yellow (E 104) 2.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules
Yellow and odourless granules.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses and ponies.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of pain and inflammation associated with musculo-skeletal
conditions in the horse
_eg_ osteoarthritic conditions, bursitis, laminitis and soft tissue
inflammation.
4.3
CONTRAINDICATIONS
Do not use in animals with renal, hepatic or cardiac disorders.
Do not use in animals where there is the possibility of
gastro-intestinal ulceration or
bleeding. Do not use in animals where there is evidence of a blood
dyscrasia.
Do not use in cases of known hypersensitivity to the active substance
or any of the
excipients.
Revised: April 2022
AN: 02931/2021
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
NSAIDs can cause inhibition of phagocytosis and hence, in the
treatment of inflammatory
conditions associated with bacterial infections appropriate
antimicrobial therapy should be
instigated.
4.5
SPECIAL PRECAUTIONS FOR USE
4.5.I SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not exceed the stated dose or duration of treatment. Dosage should
be kept to a
minimum for alleviation of symptoms.
During treatment of very young animals (less than 12 weeks) where
development of their
hepatic or renal function may be incomplete, or in aged animals which
may have these
functions impaired, as well as in ponies, additional risk may be
involved. In these cases,
doses should be accurately calculated and patients monitored closely.
During treatment, do not restrict the consumption of water. Avoid use
in any dehydrated,
hypovolaemic or hypotensive animals as there may be an in
                                
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